2018;28(2):186193. Defendant-awarded cases by US region (right). Excessive hemorrhage occurred in two patients (1.8%) with coagulation disorders. Of note, while only 38.2% (n = 26) of cases in our study mentioned the use of intraoperative radiographic confirmation, only one of these cases reported that the misplaced screw had been caught prior to leaving the operating room, which had resulted in an inadvertent dural tear and L5 nerve root injury. 2013;123(9):20992103. This study revealed an overall accuracy rate of 95.2% of mainly percutaneously inserted pedicle screws according to the classification of Zdichavsky et al. Dr. Shaffrey holds patents with, receives royalties from, and is a consultant for Medtronic, NuVasive, and Zimmer Biomet; is a stockholder in NuVasive; is a consultant for K2M, Stryker, SI Bone, and In Vivo; and has received grants from the ISSG, DePuy Synthes, and AO Spine. Incidence and costs of defensive medicine among orthopedic surgeons in the United States: a national survey study. A total of 247 screws (9.07%) were BMP, 52 (1.91%) were IMP, and 29 (1.06%) were considered SAR. Lumbar Spine Surgery. Continued clinical experience with various pedicle screw implant systems has led to ongoing improvements in system design to minimize implant failure rates and to improve ease of system application. Spine 14:472476, 1989. In addition, the median time to judgment is substantial, particularly for defendant verdicts, spanning over 4.5 years from the time of surgery. The plaintiff underwent revision surgery in May 2013. Both of these patients complained of thigh pain but refused any additional surgery. In the Kane County medical malpractice lawsuit of Melissa Nyquist v. Dr. Taras Masnyk and DuPage Neurosurgery, S.C., 06 L 421, the plaintiffs attorney was unable to convince the jury that the plaintiffs medical complications were caused by the defendants negligence. Back pain/spinal stenosis and neurogenic claudication/radiculopathy were the most frequently reported indications for the index surgery, accounting for 13 (19.1%) and 11 (16.2%) cases, respectively. McAfee PC, Weiland DJ, Carlow JJ: Survivorship analysis of pedicle spinal instrumentation. Studdert DM, Mello MM, Sage WM, et al. Quinnell RC, Stockdale HR: Some experimental observations of the influence of a single lumbar floating fusion on the remaining lumbar spine. Moreover, local court rulings are not included in the Westlaw Edge database; however, this is unlikely to present meaningful bias given that malpractice claims are generally filed in state courts. 5. There were nine instrumentation failures at the thoracolumbar area (seven patients), lumbar area (one patient), and lumbosacral area (one patient). Among the plaintiff-awarded cases, 13 (61.9%) were decided by jury trial, 7 (33.3%) by settlement, and 1 (4.8%) by arbitration. Study design: However, this difference was no longer significant when adjusted for inflation ($1,016,000 $90,875 vs $1,630,000 $422,405, p = 0.09). 15. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. FOIA Nayar G, Blizzard DJ, Wang TY, et al. Dr. K. D. Than is a consultant for Bioventus and receives honoraria from DJO and LifeNet Health. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? Finally, considering the problems of balance, it seems that failure to properly evaluate any preexisting scoliosis was a main cause of this important complication. The case facts centered on a spinal surgery the 34 year-old plaintiff had undergone at Central DuPage Hospital. Epub 2014 Jun 13. Svider PF, Husain Q, Kovalerchik O, et al. Unable to load your collection due to an error, Unable to load your delegates due to an error. Spine 6:263267, 1981. Lali Sekhon, Jocelyn Idema & more: 4 spine and neurosurgeons making headlines, Spinal cord stimulation trumps medication for pain reduction 7 takeaways, Dr. Khalid Kurtom on major trends in spinal cord injury surgery. Study supervision: Goodwin, Karikari, Shaffrey, Abd-El-Barr, KD Than. Wolters Kluwer Health Acta Neurochir (Wien). Review of neurosurgery medical professional liability claims in the United States. The literature gave a range of screw misplacement rates detected on postoperative imaging of between 1% and 18%, with the rate generally considered to be around 10%. The rod is held in place by "pedicle screws," which the surgeon must insert into the pedicles. J Bone Joint Surg 45A:11591170, 1963. Median screw misplacement rate was 10% in group A and 13% in group B. Pedicle screw placement is a common procedure. Of the 112 patients, 57 patients had a lumbar degenerative disorder, (lumbar degenerative spinal canal stenosis in 23 patients, degenerative or spondylolytic spondylolisthesis in 12 patients, postlaminectomy instability or stenosis in 20 patients, and recurrent disc prolapse in two patients), 42 patients had spinal cord injury, eight patients had infection, and five patients had a spinal tumor (Table 1). Unfortunately, the plaintiffs attorney was unable to offer an alternative theory of surgical negligence that would refute the defendants explanation. The states with the most cases included California (n = 10, 14.7%), New York (n = 6, 8.8%), Pennsylvania (n = 6, 8.8%), and Illinois (n = 5, 7.3%; Table 2). The rate of misplaced pedicle screws ranges from 1.1% to 28.8%, 10 although neurologic injury from misdirected pedicle screws has been reported to occur in 0% to 12% of patients. Pedicle screw construct have become one of the most practiced procedure in spinal surgery. Spine Deform. It is an effective procedure in that it provides an almost immediate stabilization of the spine [ 2-5 ]. 2014 Sep;21(3):320-8. doi: 10.3171/2014.5.SPINE13567. J Bone Joint Surg 61A:201207, 1979. 15. Ultimately, additional prospective, multiinstitutional large-volume studies are needed to validate these findings, and future studies should evaluate the long-term impact on the routine use of intraoperative imaging confirmation and/or computer- or robot-assisted navigation on the frequency and success of malpractice claims related to misplaced pedicle and lateral mass screws. Although pedicle screw fixation opened a new horizon of spinal surgery by providing rigid fixation of the spine, it is a technically demanding procedure with potential complications including medical complications, hardware and technical problems, and long-term changes of junctional motion segments. Pediatric pedicle screw placement using intraoperative computed tomography and 3-dimensional image-guided navigation. Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). Screws penetrating the anterior cortex and abutting vascular structures, particularly aortic abutment with left-sided screws, which can lead to erosion and pseudoaneurysms. J Pediatr Orthop. JAMA. 3). 4. Rothberg MB, Class J, Bishop TF, et al. Surg Neurol. In our opinion, these problems may be prevented by applying the following principles: limitation of spine arthrodesis to the pathologic levels, inclusion of already extensive changes at the level above or below the planned arthrodesis into the arthrodesis, restoration of postoperative sagittal and coronal alignment, and avoidance of impingement syndrome from the adjacent nonfused facets. To evaluate the accuracy of pedicle screw placement using a novel classification system to determine potentially significant screw misplacement. The initial search using the terms above returned 3654 cases. West III JL, Bradford DS, Ogilvie JW: Results of spinal arthrodesis with pedicle screw-plate fixation. N Engl J Med. Nyquist followed a medical malpractice lawsuit against Dr. Masnyk for his surgical error, alleging that the surgeon had improperly positioned the right L4 pedicel screw which had resulted in a nerve root injury and Nyquists subsequent foot drop. Svider PF, Kovalerchik O, Mauro AC, et al. The remaining eight patients, including two patients with spinal trauma, five patients with infection, and one patient with a tumor, had anterior and posterior procedures. Accuracy of fluoroscopically-assisted pedicle screw placement: analysis of 1,218 screws in 198 patients. Screws were divided into four categories: screws at risk (SAR), indeterminate misplacements (IMP), benign misplacements (BMP), accurately placed (AP). In addition, hardware failures were observed in 12 patients (10.7%), junctional problems were seen in five patients (4.5%), problems in the instrumented segments were seen in 39 patients (34.7%), and problems of balance occurred in five patients (4.5%). The development of the transpedicle screw has provided control of the vertebral motion segment in each plane, resisting any type of load. Gertzbein SD, Robbins SE: Accuracy of pedicular screw placement in vivo. 38. (%), Pseudarthrosis requiring revision surgery. This study has shown that percutaneous insertion of pedicle screws in the lumbar spine is a safe and reliable technique, and despite the low misplacement rate of only 6.6%, it should be kept in mind that the surgical procedure is technically demanding and should be performed only by experienced spine surgeons. Copyright 1944-2023 American Association of Neurological Surgeons, Copy this link, or click below to email it to a friend. A review of medicolegal malpractice suits involving cervical spine: what can we learn or change? Objective: Katonis PG, Kontakis GM, Loupasis GA, et al: Treatment of unstable thoracolumbar and lumbar spine injuries using Cotrel-Dubousset instrumentation. Rynecki ND, Coban D, Gantz O, et al. We avoid using sharp automated drilling, and probe fully the pedicle cavity to prevent nerve root impairment. Spine 6:615619, 1981. Forty-seven intraoperative and medical complications were observed in 41 patients (36.6%). A total of 69 patients (mean age, 67.416 . Roy-Camille R, Saillant G, Mazel C: Internal fixation of the lumbar spine with pedicle screw plating. Dr. Friedlander did not order a CT or MRI until January 2013, when the pedicle screw was found to be in the wrong location and a failed fusion was diagnosed, according to the suit. Hardware problems were those related to the physical change of metal and screw position. 17,18,31,39 Edwards 6 showed that solid arthrodesis developed in 96% of patients without previous surgery, whereas 84% of patients having secondary operations experienced a similar result. Jena AB, Seabury S, Lakdawalla D, Chandra A. The medicolegal landscape of spine surgery: how do surgeons fare? While reported to be one of the best legal research resources available and utilized in several previous studies,7,14,16,23,24 available court documents and clinical/operative details are highly variable and greatly limited among case files. All case demographics are summarized in Table 1. A retrospective review of charts, x-rays (XRs) and computed tomography (CT) scans was performed. 9. Malpractice risk according to physician specialty. First, this is a retrospective analysis of cases obtained from the web-based Westlaw Edge legal research database. (A) Anteroposterior and (B) lateral radiographs taken 1 year after surgery show upper screw breakage in the application of a short Cotrel-Dubousset construct in a T12 burst fracture. Of note, the award amount for one settlement case was undisclosed. Mohar J, Vali M, Podovovnik E, Mihali R. Eur Spine J. Neurosurgical practice liability: relative risk by procedure type. Two-dimensional (2D) fluoroscopy-guided percutaneous pedicle screw (PPS) placement is currently the most widely applied instrumentation for minimally invasive treatment of spinal injuries requiring stabilization. Agarwal N, Gupta R, Agarwal P, et al. A total of 2396 screws were placed accurately (87.96%). doi: 10.1097/BRS.0b013e31822a2e0a. Cerebrospinal fluid fistulas. The majority of screws were misplaced in the lumbar spine for both plaintiff- and defendant-awarded cases (66.7% vs 57.4%, respectively, p = 0.564; Table 1). 30. Ann Thorac Surg. 13. This study quantifies the rate of screw misplacement on a per-patient basis to highlight its effect on potential morbidity. Although the rate of the reported medical complications was high (36.5%), these did not significantly affect the final clinical outcome of the current patients. After the removal of duplicates, a total of 68 unique cases met our inclusion criteria and were included for analysis. Error in trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. 2. Wiltse LL, Spencer CW: New uses and refinements of the paraspinal approach to the lumbar spine. Legal liability in iatrogenic orbital injury. Crawford MJ, Esses SI: Indications for pedicle fixation: Results of NASS/SRS faculty questionnaire: North American Spine Society and Scoliosis Research Society. Plaintiff award amounts were adjusted for inflation as of April 2020 using an online inflation calculator provided by the US Bureau of Labor Statistics (https://www.bls.gov/data/inflation_calculator.htm). Katonis, Pavlos MD*; Christoforakis, Joseph MD*; Aligizakis, Agisilaos C. MD*; Papadopoulos, Charalampos MD*; Sapkas, George MD, DSc**; Hadjipavlou, Alexander MD*. Introduction. Patient safety: disclosure of medical errors and risk mitigation, Neurosurgical practice liability: relative risk by procedure type. Spine 24:23522357, 1999. Recently, robot-assisted pedicle screw implantation has been increasingly utilized at large-volume academic centers. Despite these failures, solid spinal arthrodesis was obtained in all patients. 28. Malpractice litigation following spine surgery. ObjectThe goal of this study was to determine the incidence of screw misplacement and complications in a group of 102 patients who underwent transpedicle screw fixation in the lumbosacral spine with conventional open technique and intraoperative.
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